PRODUCT USE ISSUE and Risperdal

PRODUCT USE ISSUE Symptoms and Causes

The products you use for cleaning, carpentry, auto repair, gardening, and many other household uses can contain ingredients that can harm you, your family, and the environment. These include

Oven and drain cleaners

Laundry powder

Floor polish

Paint thinners, strippers and removers

Pesticides

Grease and rust removers

Motor oil and fuel additives

Arts and craft supplies

Toxic substances in these products can cause harm if inhaled, swallowed, or absorbed through the skin. People respond to toxic substances in different ways. At high doses a toxic substance might cause birth defects or other serious problems, including brain damage or death.

To avoid problems, keep products in the containers they come in and use them exactly as the label says. Follow label directions or get medical help if you swallow, inhale or get them on your skin.

PRODUCT USE ISSUE Clinical Trials and Studies

Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses. People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff.

The primary end point will be change in PANSS Positive Subscale Score in the high dose group using a mixed model ANOVA; change in PANSS; time to discontinuation for lack of efficacy and tolerability; change in cognitive domain scores; comparative incidence and time course of EPS, hyperprolactinemia, plasma lipids, weight gain, and other side effects between treatments

Aripiprazole concentration in venous and capillary plasma; Paliperidone concentration in venous and capillary plasma; Olanzapine concentration in venous and capillary plasma; Quetiapine concentration in venous and capillary plasma; Risperidone concentration in venous and capillary plasma; Number of participants with an adverse event as a measure of safety

Cmax, Tmax, for Relative bioavailability of LY03004 compared to Risperdal® Consta®; Number of Participants with Adverse Events as a Measure of Safety and Tolerability; The change of the PANSS score for the Preliminary efficacy of LY03004

Peak Plasma Concentration (Cmax) for Active Moiety; Trough Plasma Concentration (Cmin) for Active Moiety; Area under the curve to the last quantified concentration (AUClast) and Area under the curve extrapolated to infinity (AUC∞) for Active Moiety; Terminal rate constant (λz), Terminal half-life (t1/2) and Time to peak concentration (tmax) for Active Moiety; Peak Plasma Concentration (Cmax) for Risperidone and 9OH-Risperidone Moieties; Trough Plasma Concentration (Cmin) for Risperidone and 9OH-Risperidone Moieties; Occurrence, nature, onset time, duration, intensity, action taken, outcome and relationship to study drug of AEs as a Measure of Safety; Area under the curve to the last quantified concentration (AUClast) and Area under the curve extrapolated to infinity (AUC∞) for Risperidone and 9OH-Risperidone Moieties; Terminal rate constant (λz), Terminal half-life (t1/2) and Time to peak concentration (tmax) for Risperidone and 9OH-Risperidone Moieties; Area Under the Concentration-time Curve​ for To perform a descriptive comparison of the PK data between the gluteal and the deltoid muscle administration of the injectable ISM formulation

The number of days patients are without delirium during the study period (delirium-free days); Daily prevalence of delirium as indicated by a positive Confusion Assessment Method in the ICU (CAM-ICU); Resolution of delirium as indicated by a negative Confusion Assessment Method in the ICU (CAM-ICU) for more than 24 hours; The number of patients who require rescue medications, the type of rescue medications utilized, and the amount of rescue medications per day; The number of patients who receive sedative agents, amount of midazolam equivalents per day, and the number of days in which patients receive a sedative agent; The number of patients who receive pain medications, amount of fentanyl equivalents per day, and the number of days in which patients receive a pain medication; The number of hours spent agitated (RASS score between +4 and +2) as a percent of the time that the study drug was administered; The number of hours spent excessively sedated or in a coma state (RASS score between -4 to -5) as a percent of the time that the study drug was administered; The duration of mechanical ventilation from initial intubation to extubation as long as the patient remained extubated for more than 48 hours.; The number of days that the patients were alive and breathing without assistance during the study period (ventilator-free days); The number of episodes and number of patients who experience clinically significant QTc prolongation (≥ 500 msec or an increase of more than 60 msec from baseline); The number of episodes and number of patients who experience clinically significant extrapyramidal effects (as evidenced by a positive Simpson-Angus Scale Score); All-cause mortality and 28-day mortality

Cognitive deficits as assessed by tests measuring the MATRICS cognition domains; Negative schizophrenic symptoms; Reduction in side effects of risperidone; Abnormality in P50 inhibition; Nicotine use among all participants who smoke

Incidence of adverse events; Health of the patients, assessed through a complete medical examination including physical examination, electrocardiogram (ECG) and vital signs.; Pharmacokinetics: Plasma area under the concentration-time curve (AUC) of RO5545965; Pharmacokinetics: Plasma area under the concentration-time curve (AUC) of risperidone

Scores on an analogue measure of responsiveness to skills training.; Scores on a measure of skills acquisition and performance pre-post a 3-month skills training group.; Interview measures of social functioning.; Neurocognitive functioning.; Symptomatology.

If you think you may have a medical emergency, call your doctor or 911 immediately.

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